FDAFDA · Food and drugs·Recall number D-0095-2025
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.
Published December 11, 2024 · Recall initiated: November 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DILTIAZEM HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Nationwide in the USA
- UPC
- 0368462562017
- Lot
- Lot #: 17222470, 17230680, 17222547, Exp. Date 11/30/2024; 17230304, Exp. Date, 12/31/2024; 17230598, Exp. Date, 02/2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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